Attachment 3 - Performance Work Statement.docx

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Testing and Certification – Sterile Compounding Areas at Brooke Army Medical Center, JBSA Ft. Sam Houston, TX
Solicitation number
W81K00-26-Q-A163
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This is a Performance Work Statement (PWS) for testing and certification services of sterile compounding areas at Brooke Army Medical Center (BAMC), located at JBSA Fort Sam Houston, Texas. The contractor shall provide non-personnel services including semi-annual testing and inspection of pharmacy cleanroom equipment and facilities to maintain compliance with USP 797 and USP 800 regulations. Services include semi-annual testing of five laminar flow/clean bench hoods, six vertical flow/bio hoods, five anterooms, and six buffer rooms across multiple BAMC locations (Main Inpatient, COTO, IDS, PEDS, HEMONC, and Nuclear). The contractor must collect 31 monthly service samples totaling 372 samples annually and provide re-certification and repair services on an as-needed basis. Testing encompasses primary engineering controls (PECs) and secondary engineering controls (SECs), including HEPA filter leak and efficiency testing, viable and non-viable particle count analysis, air velocity measurements, microbial air and surface sampling, and bacterial and fungal speciation in accordance with applicable standards.

The contractor must furnish all personnel, equipment, supplies, facilities, and supervision necessary to perform the work. Field service technicians must be certified by CETA or NEBB and possess a minimum of two years' experience within the last 36 months; the laboratory conducting microbial testing must be nationally accredited for environmental microbiology analysis. No subcontracting is permitted. Services shall be performed Monday through Friday, 7:30 a.m. to 4:30 p.m., except federal holidays and government facility closures. The contractor must complete all semi-annual re-certifications no later than the third Friday of each month, with no more than two individual pharmacy locations certified monthly unless exceptions are approved by the Contracting Officer's Representative (COR). Field Service Reports must be submitted within 72 hours of completion and environmental sampling incubation, including specific location, USP testing validation results, test descriptions, acceptable result ranges, actual results, pass/fail designations, and performance summaries. The contractor is responsible for safeguarding government property, maintaining security protocols, complying with installation access control requirements, and developing a Quality Control Plan addressing non-disclosure agreements, organizational conflict of interest mitigation, and procedures for preventing defective services.

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PERFORMANCE WORK STATEMENT (PWS)

Testing and Certification – Sterile Compounding Areas

Part 1 General Information

1.1.1 General: This is a non-personnel services contract to provide Clean Room Certification. The Government shall not exercise any supervision or control over the contract service providers performing the services herein. Such contract service providers shall be accountable solely to the Contractor who, in tum is responsible to the Government.

1.1.2 Description of Services/Introduction: The contractor shall provide all personnel, equipment, supplies, facilities, transportation, tools, materials, supervision, and other items and non-personal services necessary to perform Clean Room Certification as defined in this Performance Work Statement except for those items specified as government furnished property and services. The contractor shall perform to the standards in this contract.

1.1.3 Background: Testing and inspection services are required in order to maintain compliance with 797 & 800 USP regulations. The purpose is to provide the best maintenance, repair, and certification services for pharmacy cleanroom equipment and facilities in accordance with manufacturer's maintenance manuals, specification, and quality control policies and procedures governed by Brooke Army Medical Center (BAMC) Department of Pharmacy, Biomedical Engineering Services (BES) and the respective using activity. Information concerning the systems to be serviced is furnished from the best available sources. HOWEVER, this shall not relieve the Contractor of the requirement for visiting the location of the systems listed and to be thoroughly familiarized with all components associated with the item(s) and conditions under which the work is to be performed.

1.1.4 Scope: The Contractor shall provide non-personal testing and inspection services for multiple sterile compounding areas at BAMC on JBSA Fort Sam Houston, TX. These services include the semi-annual testing and inspection of 5 laminar flow/clean bench hoods with viable air surface sampling at the Main Inpatient, COTO, and IDS locations, along with 6 vertical flow/bio hoods at the PEDS, HEMONC, and Nuclear locations. The scope also covers semi-annual inspections of 5 anterooms, 6 buffer rooms, testing for 17 air filters, and air testing in hazardous drug storage areas. Furthermore, the contractor will collect 31 monthly service samples, totaling 372 samples per year, and will provide re-certification and repair services on an as-needed basis. Vendor will conduct applicable tests on primary engineering controls (PECs) including but not limited to: HEPA filter leak and efficiency; viable and non-viable particle count larger than 0.5 micron; air velocity (flow rates) for the chamber, supply, and exhaust; microbial air and surface sampling in accordance with USP 797; and speciation of all bacteria and fungi testing. Vendor will conduct applicable test on secondary engineering controls (SECs), divided into anterooms, buffer rooms, and segregated compounding areas (SCA), including but not limited to Room HEPA filter leak and efficiency; viable and non- viable particle count larger than 0.5 micron; air changes of the space per hour; microbial air and surface sampling in accordance with USP 797; speciation of all bacteria and fungi testing, room temperature room pressure relative to adjacent spaces, and room humidity. Vendor shall provide a holistic certification for each pharmacy clean room in a Field Service Report (FSR). Each FSR will include a combination of individual PEC, SEC, and associated equipment test and validation results. Complete FSR to validate pharmacy cleanroom operational. The contractor shall perform all re-certifications and maintenance activities according to manufacturer specifications.

1.1.5 Objectives:

· The objective of this contract to maintain compliance with USP 797 & 800 requirements.

· The contractor shall provide semi-annual and unscheduled re-certification (and associated maintenance activities of pharmacy cleanroom equipment and associated cleanroom devices located at BAMC, see equipment listing for details.

1.2.1 General Information:

1.2.2 Quality Control Plan (QCP): The contractor shall develop and maintain an effective quality control program to ensure services are perfonned in accordance with this PWS. The contractor shall develop and implement procedures to identify, prevent, and ensure non-recurrence of defective services. The contractor's quality control program is the means by which he assures himself that his work complies with the requirement of the contract. The QCP is to be delivered with the contractor's proposal and a comprehensive written QCP shall be submitted to the KO and COR within 5 working days when changes are made thereafter. After acceptance of the quality control plan the contractor shall receive the contracting officer's acceptance in writing of any proposed change to his QC system.

1.2.3 Quality Assurance: Quality Assurance: The government shall evaluate the contractor's perfonnance under this contract in accordance with the Quality Assurance Surveillance Plan. This plan is primarily focused on what the Government must do to ensure that the contractor has performed in accordance with the performance standards. It defines how the performance standards will be applied, the frequency of surveillance, and the minimum acceptable defect rate(s).

1.2.3 Recognized Holidays: The contractor is not required to perform services on holidays.

New Year's Day Martin Luther King Jr.'s Birthday President's Day Memorial Day Independence Day June 19 - Juneteenth Labor Day Columbus Day Veteran's Day Thanksgiving Day Christmas Day

1.2.4 Operating Hours: The contractor is responsible for conducting business, between the hours of 7:30 - 4:30. Monday thru Friday except Federal holidays or when the Government facility is closed due to local or national emergencies, administrative closings, or similar Government directed facility closings. For other than firm fixed price contracts, the contractor will not be reimbursed when the government facility is closed for the above reasons. The Contractor must at all times maintain an adequate workforce for the uninterrupted performance of all tasks defined within this PWS when the Government facility is not closed for the above reasons. When hiring personnel, the Contractor shall keep in mind that the stability and continuity of the workforce are essential.

1.2.5 Place of Performance: The work to be performed under this contract will be performed at BAMC.

1.3 Security Requirements: The contractor shall be responsible for safeguarding all government property provided for contractor use. The contractor shall safeguard information of a confidential or sensitive nature. The contractor shall not disclose or cause to be disseminated any information concerning the operation of the MTF that could result in or increase the likelihood of the possibility of breach of security or interrupt the continuity of operations or which breach the requirements of the Federal Privacy Act of 1974.

1.3.1 PHYSICAL Security: The contractor shall be responsible for safeguarding all government equipment, information and property provided for contractor use if performing in a government facility. At the close of each work period, government facilities, equipment, and materials shall be secured. In case of the loss of any Government equipment, information and property the Contractor shall be counsel and may be reported to the KO to request reimbursement by the Contractor.

1.3.2 In the event keys, other than master keys, are lost or duplicated, the Contractor shall, upon direction of the Contracting Officer, re-key or replace the affected lock or locks; however, the Government, at its option, may replace the affected lock or locks or perform re-keying. When the replacement of locks or re-keying is performed by the Government, the total cost of re-keying or the replacement of the lock or locks shall be deducted from the monthly payment due the Contractor. In the event a master key is lost or duplicated, all locks and keys for that system shall be replaced by the Government and the total cost deducted from the monthly payment due the Contractor.

1.3.3. The Contractor shall prohibit the use of Government issued keys/key cards by any persons other than the Contractor's employees. The Contractor shall prohibit the opening of locked areas by Contractor employees to permit entrance of persons other than Contractor employees engaged in the performance of assigned work in those areas, or personnel authorized entrance by the Contracting Officer.

1.3.4 Lock Combinations: The Contractor shall establish and implement methods of ensuring that all lock combinations are not revealed to unauthorized persons. The Contractor shall ensure that lock combinations are changed when personnel having access to the combinations no longer have a need to know such combinations. These procedures shall be included in the Contractor's Quality Control Plan.

1.3.5 Special Qualifications: The field service technician shall be authorized, certified, and trained in the certification of pharmacy primary and secondary engineering controls (CETA or NEBB certification). Additionally, the service technician shall have a minimum of two years’ experience within the last 36 months. The laboratory conducting any related microbial testing shall be nationally accredited to conduct environmental microbiology sample testing and analysis. The contractor company shall be certified to conduct cleanroom certification (NEBB or equivalent). Under no circumstances can the activities of this contract be subcontracted.

1.4 Installation Access: Access to U.S. installations, buildings and controlled areas is limited to personnel who meet security criteria and are authorized. Failure to submit required information/data and obtain required documentation or clearances will be grounds for denying access to U.S. installations, buildings and controlled areas. The Contractor shall ensure that any subcontractors used in performance of this contract complies with these requirements and that all employees, of both the Contractor and any subcontractor utilized by the Contractor, are made aware of and comply with these requirements.

The Contractor shall be aware of and comply with the requirements associated with Installation Access Control. The Government is not liable for any costs associated with performance delays due solely to a firm’s failure to comply with Installation Access Control System (IACS) processing requirements.

The Contractor shall return installation passes to the issuing IACS office when the contract is completed or when a Contractor employee no longer requires access.

1.4.1 Installation Pass Log: In addition, the Contractor shall provide the Contracting Officer, via the COR, an Initial Installation Pass Log. The log must at a minimum contain the following information. The log shall be updated as employees are added or removed. The Updated Installation Pass Log shall be current and available at any time upon request by the Government and submitted to the COR within five (5) days after any changes to the log.

1.4.2 Individual Termination or Expiration of Employment: The Contractor shall collect the installation access passes the same day employment of an individual has expired or has been terminated and shall return them to the issuing office.

1.4.3 Contract Termination or Cancellation: Upon termination or cancellation of this contract, the Contractor shall collect all outstanding installation access passes and return them to the issuing office.

1.4.4 Operations Security (OPSEC) Requirements: Contractor personnel shall adhere to facility security policies and restrictions. The Contractor shall immediately report suspicious activities to security personnel.

1.5 Post Award Conference/Periodic Progress Meetings: The Contractor shall attend any post award conference convened by the contracting activity or contract administration office in accordance with FAR Subpart 42.5. The Contracting Officer, COR, and other Government personnel, as appropriate, may meet periodically with the Contractor to review the Contractor's performance. At these meetings the Contracting Officer will apprise the Contractor of how the Government views the Contractor's performance and the Contractor shall apprise the Government of problems, if any, being experienced. Appropriate action shall be taken to resolve outstanding issues. These meetings shall be at no additional cost to the Government.

1.6 Contracting Officer’s Representative (COR): Refer to Part 2 of this PWS for the definition of a COR. As determined by the Contracting Officer, a COR will be appointed and identified by letter of designation, a copy of which will be provided to the Contractor by the Contracting Officer. The designation letter states the responsibilities and limitations of the COR, especially with regard to changes in cost or price, estimates, or changes in delivery dates. The COR is not authorized to change any of the terms and conditions of the resulting order. The COR monitors all technical aspects of the contract and assists in contract administration. The COR is not authorized to obligate the Government. If the work is not written in the contract, the COR is not authorized to request new work. The COR is authorized to perform the following functions: assure that the Contractor performs the technical requirements of the contract, perform inspections necessary in connection with contract performance, maintain written and oral communications with the Contractor concerning technical aspects of the contract, issue written interpretations of technical requirements, including Government drawings, designs, specifications, monitor Contractor's performance and notifies both the Contracting Officer and Contractor of any deficiencies, coordinate availability of Government property, and coordinate site entry of Contractor personnel.

1.7 Contractor Travel: No travel is required during the performance of this contract

1.8 Non-Disclosure Requirements: Performance under this contract may require the Contractor to access data and information proprietary to a Government agency, another Government Contractor, or of such nature that its dissemination or use other than as specified in this work statement would be adverse to the interests of the Government or others. The Contractor and Contractor personnel, shall not divulge or release data or information developed, or obtained under performance of this PWS, except to authorized Government personnel or upon written approval of the Contracting Officer. The Contractor shall not use, disclose, or reproduce proprietary data, which bears a restrictive legend, other than as specified in this PWS. All documentation showing individual names or other personal information shall be controlled and protected under the provisions of the Privacy Act of 1974, Public Law 93-579, 5 United States Code (U.S.C.) Section 552a.

1.8.1 Protection of Government and Contract Information: Per Public Use Notice of Limitations stated by Defense imagery Management operations Center and contained at www.dimoc.mil/resources/limitations/ , the Contractor shall not cite any information (e.g., contract information, pictures, locations, etc.) obtained through this contract on any hard copy or digital marketing tools to include its company website.

1.8.2 Non-Disclosure Statements: The Contractor shall provide signed non-disclosure agreements to the Government. Disclosure of information by Contractor personnel may result in removal of Contractor personnel from performance under this contract.

1.8.3 Organizational Conflict of Interest (OCI): Contractor and subcontractor personnel performing work under this contract may receive, have access to or participate in the development of proprietary or source selection information (e.g., cost or pricing information, budget information or analyses, specifications or work statements, etc.) or perform evaluation services which may create a current or subsequent OCI as defined in FAR Subpart 9.5. The Contractor shall notify the Contracting Officer immediately whenever it becomes aware that such access or participation may result in any actual or potential OCI and shall promptly submit a plan to the Contracting Officer to avoid or mitigate any such OCI. The Contractor’s OCI Mitigation Plan will be determined to be acceptable solely at the discretion of the Contracting Officer. In the event the Contracting Officer unilaterally determines that any such OCI cannot be satisfactorily avoided or mitigated, the Contracting Officer may affect other remedies as he or she deems necessary, including prohibiting the Contractor from participation in subsequent contracted requirements which may be affected by the OCI.

PART 2

DEFINITIONS & ACRONYMS

2. Definitions and Acronyms

2.1 Definitions: Although not inclusive of every term used within this PWS, the following provides a list of definitions used throughout this PWS and commonly used in the acquisition field.

Contracting Officer – means a person with the authority to enter into, administer, and/or terminate contracts and make related determinations and findings on behalf of the Government. Note: The only individual who can legally bind the Government.

Contracting Officer's Representative (COR) – As defined in DFARS 202.101, means an individual designated and authorized in writing by the Contracting Officer to perform specific technical or administrative functions. DoD Instruction (DoDI) 5000.72, Part II Definitions states the following when defining a COR: “Defined in subpart 202.101 of Reference (f). Any individual delegated responsibilities pursuant to subpart 1.602-2 of Reference (e), regardless of local terminology, must be certified in accordance with this instruction. For example, local terminology can be COR, Contracting Officer’s technical representative, technical point of contact, technical representative, alternate COR, administrative COR, assistant COR, line item manager, task order manager, quality assurance personnel, quality assurance evaluator, or COR management.” In addition, Army Regulation 70-13, Chapter 2, paragraph 2-2g, states, in part, the following when providing other surveillance support personnel to assist the COR when needed, “…These other surveillance support personnel may serve as on-site representatives of the COR in performance of actual contract surveillance if they meet all COR requirements and have been appointed by the Contracting Officer as alternate CORs.”

Contractor – means a supplier or vendor awarded a contract to provide specific supplies or service to the Government. The term used in this contract refers to the prime.

Contractor-acquired Property - means property acquired, fabricated, or otherwise provided by the Contractor for performing a contract and to which the Government has title.

Day – means, unless otherwise specified, a calendar day.

Defective Service – means a service output that does not meet the standard of performance associated with the Performance Work Statement.

Deliverable – means anything that can be physically delivered, but may include non-manufactured things such as meeting minutes or reports.

Government-furnished Property – As reflected in FAR 52.245-1, Government-furnished Property “means property in the possession of, or directly acquired by, the Government and subsequently furnished to the Contractor for performance of a contract. Government-furnished property includes, but is not limited to, spares and property furnished for repair, maintenance, overhaul, or modification. Government-furnished property also includes contractor-acquired property if the contractor-acquired property is a deliverable under a cost contract when accepted by the Government for continued use under the contract

Government Property - means all property owned or leased by the Government.Government property includes both Government-furnishedand Contractor-acquired property. Government property includes material, equipment, special tooling, special test equipment, and real property. Government property does not include intellectual property and software.

Property Administrator - means an authorized representative of the Contracting Officer appointed in accordance with agency procedures, responsible for administering the contract requirements and obligations relating to Government property in the possession of a Contractor.

High Level Objective (HLO) – means a key overarching result-based objective for a project necessary to achieve the project’s vision. HLOs are similar to Level 2 in a Work Breakdown Structure. Each HLO may contain several statements to flesh out the areas necessary to meet the objective.

Physical Security – means that part of security concerned with physical measures designed to safeguard personnel; to prevent unauthorized access to equipment, installations, material, and documents; and to safeguard against espionage, sabotage, damage, and theft.

Quality Assurance – (or Government contract quality assurance) means the various functions, including, inspection, performed by the Government to determine whether a Contractor has fulfilled the contract obligations pertaining to quality and quantity.

Quality Assurance Surveillance Plan (QASP) – means the key Government-developed surveillance process document, and is applied to Performance-Based Service Contracting (PBSC). The QASP is used for managing Contractor performance assessment by ensuring that systematic quality assurance methods validate that Contractor quality control efforts are timely, effective, and are delivering the results specified in the contract or task order. The QASP directly corresponds to the performance objectives and standards (i.e., quality, quantity, timeliness) specified in the Performance Work Statement (PWS). It provides specific details on how the Government will survey, observe, test, sample, evaluate, and document Contractor performance results to determine if the Contractor has met the required standards for each objective in the PWS. The QASP, with very few if any exceptions, is an internal to Government document.

Quality Control – means all necessary measures taken by the Contractor to assure that the quality of an end product or service shall meet contract requirements.

Statement – means the specific results-based activities required to satisfy HLOs. A statement contains a result, the context of the statement, and the required action(s). Statements focus on “what” is to be accomplished; however they are not prescriptive in describing “how” the outcome is to be achieved. Each HLO may have several statements to flesh out the areas necessary to meet the objective. Statements are similar to Level 3 in a Work Breakdown Structure.

Subcontractor – means one that enters into a contract with a prime Contractor. The Government does not have privity of contract with the subcontractor.

Work Day - The number of hours per day the Contractor provides services in accordance with the contract.

Work Week - Monday through Friday, unless otherwise specified.

2.2 Acronyms: Although not inclusive of every term used within this PWS, or that may be included in an acquisition, the following provides a list of acronyms commonly used in the acquisition field.

ACORAlternate Contracting Officer's Representative
AEArmy in Europe
AFARSArmy Federal Acquisition Regulation Supplement
AHAActivity Hazard Analysis
AORArea of Responsibility
ARArmy Regulation
ATAnti-terrorism
ATCTSArmy Training Certification Tracking System
CACCommon Access Card
CCEContracting Center of Excellence
CFEConventional Forces Europe
CFRCode of Federal Regulations
CONUSContinental United States (excludes Alaska and Hawaii)
CORContracting Officer’s Representative
COTSCommercial-Off-the-Shelf
DADepartment of the Army
DD250Department of Defense Form 250 (Receiving Report)
DD254Department of Defense Contract Security Requirement List
DFARSDefense Federal Acquisition Regulation Supplement
DMDCDefense Manpower Data Center
DoDDepartment of Defense
FARFederal Acquisition Regulation
FRGFederal Republic of Germany
GFPGovernment Furnished Property
HLOHigh Level Objective
HIPAAHealth Insurance Portability and Accountability Act of 1996
IAInformation Awareness
IACInstallation Access Control
IACOInstallation Access Control Office
IDIdentification
IGCEIndependent Government Cost Estimate
ITInformation Technology
JTRJoint Travel Regulation
JPASJoint Personnel Adjudication System
KOContracting Officer
OCIOrganizational Conflict of Interest
OCONUSOutside Continental United States (includes Alaska and Hawaii)
ODCOther Direct Costs
OPSECOperations Security
PAProperty Administrator
PIIPersonally Identifiable Information
PIPOPhase In/Phase Out
POCPoint of Contact
PRSPerformance Requirements Summary
PWSPerformance Work Statement
QAQuality Assurance
QAPQuality Assurance Program
QASPQuality Assurance Surveillance Plan
QCQuality Control
QCPQuality Control Program
RARequiring Activity
RCORegional Contracting Office
SIGESafety and Health Protection Plan
TETechnical Exhibit

USAG United States Army Garrison

USAREURUnited States Army Europe
UOMUnit of Measure

PART 3

GOVERNMENT PROPERTY (GP) AND SERVICES

3. Government Property and Services

3.1 Services: The Government will make equipment and facility available to the contractor for services. Provide access to medical equipment and facility outside normal duty hours as needed. Reserve the right to obtain special services from other sources when required.

3.2 Facilities: The Government will make equipment and facility available to the contractor for services. Provide access to medical equipment and facility outside normal duty hours as needed.

PART 4

CONTRACTOR FURNISHED ITEMS AND SERVICES

4. Contractor Furnished Property and Services

4.1 General: The Contractor shall furnish all supplies, equipment, facilities and services required to perform work under this contract that are not listed under Section 3 of this PWS.

4.2 Vehicles and Equipment: The Contractor shall be required to certify, recertify, and repair primary and secondary engineering controls to maintain continued operations and requirements under the PWS.

PART 5

SPECIFIC TASKS

5.1 Basic Services: The contractor shall provide services for all re-certifications no later than the 3rd Friday of every month. No more than two individual pharmacy locations (combined ante, buffer, and SCA) can be semiannually certified in any given month. Exceptions need to be addressed with the COR or the designated representative. Scheduled re-certification must be conducted in such a manner to ensure no semi-annual certification lapses. Contractor shall complete all re-certifications for unscheduled services immediately upon completion of unscheduled service. No more than two individual pharmacy locations (combined ante, buffer, and SCA) can be recertified in any given month. Exceptions need to be addressed with the COR or the designated representative.

5.2. Field Service Technician: The field service technician shall test all safety features that are applicable to the model tested in accordance with manufacturer specifications and aforementioned published standards i.e. sash alarm, exhaust alarm, interlocks. The field service technician shall be authorized, certified, and trained in the certification of pharmacy primary and secondary engineering controls (CETA certification). Additionally, the service technician shall have a minimum of two years' experience within the last 36 months.

5.2.1. Field service technician will prepare an itemized service report for equipment that was serviced to Department of Pharmacy upon completion of services. The service report must be received by the COR or designated representative no later than 72 hrs from the time environmental sampling results are incubated and work is complete. The service report shall include the following information:

a. Call number (service calls only), usually the work order number

b. Control number

c. Nomenclature, location, model, and serial number

d. Purpose of service (scheduled or unscheduled)

e. Start date/time and completion date/time

f. Description of defect and corrective action taken

g. Itemized list of parts

h. Name of Service Technician

5.3. Testing: Major Point of Testing for environmental sampling to include but not limited to the following: Viable Environmental Air Sampling, Non-viable Environmental Air Sampling Testing, Viable Environmental Surface Sampling, Spore (fungi) Sample Air, Spore (fungi) Sample Surface, Non-viable Room Particle count, Viable Room particle counts, Uncontained Hazardous Drugs w/report (Hemoc Specific). Each air test must sample air volume of at least 400- I 000 liters (volumetric). The laboratory conducting any related microbial testing shall be nationally accredited to conduct environmental microbiology sample testing and analysis. The COR or designated representative are the only authorized DESIGNATED personnel that can request scheduled or unscheduled (repair) services. Department staff or users where medical devices are located are not authorized to request scheduled or unscheduled (repair) services.

5.4 Scheduled Services: Scheduled services are those actions relating to the preventive maintenance, operation verification and certification of primary and secondary engineering controls. The contractor will adhere to the following when performing scheduled services.

5.4.1. Contractor must coordinate expected arrival date and time with (COR) or designated representatives. Field service technician will contact COR as soon as technician arrives on-site. DESIGNATED CONTACT AND CONTACT PHONE NUMBER AND EMAIL

5.4.2. Contractor shall complete all re-certifications no later than the 3rd Friday of every month. No more than two individual pharmacy locations (combined ante, buffer, and SCA) can be semi-annually re-certified in any given month. Exceptions need to be addressed with the COR or the designated representative. Scheduled re-certification must be conducted in such a manner to ensure no semi-annual certification lapses.

5.4.3. Brooke Army Medical Center (BAMC) normal operating hours are Monday thru Friday, 0730- 1630 (7:30 am - 4:30 pm). Any services outside normal duty hours must be coordinated by the COR or designated representative.

5.4.4. Any monthly services that are generated by the contractor's automated system must be approved by the COR or designated representative before the field service technician attempts to perform services on site.

5.4.5. Prepare and provide a field service report (FSR) for all services rendered. The service report must include, at a minimum, the specific location of service, required USP<797> testing and validation, clear description of each test conducted, acceptable result range, actual test results, pass or fail designation, and summary of performance. Service reports must be received by the COR no later than 72 hrs from the time environmental sampling results are incubated and work is complete. In the event contractor receives a preliminary result, a preliminary report must be submitted to the COR.

5.4.6. Out of tolerance conditions will be documented on the FSR. If any changes or adjustments are made, these should be documented on the FSR. Any test labeled "Not Applicable" should be explained on the FSR and supported with the appropriate regulation. Any and all discrepancies will be made known to the CORI ACOR. A recommended plan of action will also be provided including a proposed remedy. An anticipated date of repair/correction will also be provided to the CORIACOR. All out of tolerance conditions identified on the FSR shall be scheduled for re-certification continuously until operation is validated.

5.5 Un-Scheduled Services: Unscheduled services are those actions relating to unplanned maintenance, operation verification and certification of primary and secondary engineering controls. The contractor will adhere to the following when performing scheduled services:

5.5.1 Contractor must coordinate expected arrival date and time with (COR) or designated representatives. Field service technician will contact COR or designated representatives as soon as technician arrives on-site.

5.5.2 Contractor shall complete all re-certifications for unscheduled services immediately upon completion of unscheduled service. No more than two individual pharmacy locations (combined ante, buffer, and SCA) can be semi-annually re-certified in any given month. Exceptions need to be addressed with the COR or the designated representative.

5.5.3 Brooke Army Medical Center (BAMC) normal operating hours are Monday thru Friday, 0730 -16 30 (7:30 am - 4:30 pm). Any services outside normal duty hours must be coordinated by the COR or designated representative

5.5.4 Any monthly services that are generated by the contractor's automated system must be approved by the COR or designated representative before the field services technician attempts to perform services on site.

5.5.5 Prepare and provide a field service report (FSR) for all services rendered. The service report must include, at a minimum, the specific location of service, required USP797 testing and validation, clear description of each test conducted, acceptable result range, actual test results, pass or fail designation, and summary of performance. Service reports must be received by the COR no later than 72 hrs. from the time environmental sampling results are incubated and work is complete. In the event contractor receives a preliminary result, a preliminary report must be submitted to the COR or designated representatives.

Out of tolerance conditions will be documented on the service report. If any changes or adjustments are made, these should be documented on the FSR. Any test labeled “Not Applicable" should be explained on the FSR and supported with the appropriate regulation. Any and all discrepancies will be made known to the COR/designated representatives. A recommended plan of action will also be provided including a proposed remedy. An anticipated date of repair / correction will also be provided to the COR/designated representatives.

PART 6

APPLICABLE PUBLICATIONS

6. Applicable Publications (Current Editions):

6.1. The Contractor must abide by all applicable regulations, publicaitons, manuals, and local policies and procedures.

USP797 USP 800

ASHRAE 110, SEFA I, ANSI/AIHA Z9.5 SETA I, IEST-RP-CC034.3

WI-CON-0224 NSF/ANSI 49

IEST-RP-CC028.l, ISO 14644-7, AGS-G00I IEST-RP-CC002.3

PART 7

ATTACHMENT AND TECHNICAL EXHIBIT LISTING

7. Attachment and Technical Exhibit List

7.1 Technical Exhibit A – Performance Requirements Summary

TECHNICAL EXHIBIT A

Performance Requirements Summary (PRS)

7.1 Attachment I/Technical Exhibit I -Performance Requirements Summary

TECHNICAL EXHIBIT 1

Performance Requirements Summary The contractor service requirements are summarized into performance objectives that relate directly to mission essential items. The performance threshold briefly describes the minimum acceptable levels of service required for each requirement. These thresholds are critical to mission success.

Performance Objective (The services required- usually a small statement)

Standard
Performance Threshold (This is the maximum error rate. It could possibly be Zero deviation from

standard) Method of Surveillance

PRS#1

The Contractor shall provide re-certification completed according to listed standards

The contractor will provide Satisfactory Quality Level
No deviation from standard
100% monitoring and periodic inspections by the COR or designated representative

PRS#2

Re-Certifications completed according to listed standards

The contractor will provide Satisfactory Quality Level
No deviation from standard
100% monitoring and periodic inspections by the COR or designated representative

PRS#3

Test all safety features based on model

The contractor will provide Satisfactory Quality Level
No deviation from standard
100% monitoring and periodic inspections by the COR or designated representative

PRS#4

Fully certified Contractor and Contractor personnel

The contractor will provide Satisfactory Quality Level
No deviation from standard
100% monitoring and periodic inspections by the COR or designated representative

PRS#5

Scheduled Services The contractor will provide Satisfactory Quality Level

No deviation from standard
100% monitoring and periodic inspections by the COR or designated representative

PRS#6

Unscheduled Services

The contractor will provide Satisfactory Quality Level
No deviation from standard
100% monitoring and periodic inspections by the COR or designated representative

PRS#7

Field Service Report format and content

The contractor will provide Satisfactory Quality Level
No deviation from standard.
100%

monitoring and periodic inspections by the COR or designated representative

PRS#8

Field Service Report timeliness

The contractor will provide Satisfactory Quality Level
No deviation from standard.
100%
monitoring and periodic inspections by the CORor designated

representative

File details come from the government source that posted it. Updated .